Date: Monday, November 9, 2015
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Olokizumab (OKZ) is a humanized
anti-interleukin-6 monoclonal antibody in development for moderate-to-severe
rheumatoid arthritis (RA) treatment. OKZ efficacy and safety were assessed in
the 12-week (wk) randomized controlled trials (RCTs)
RA0056 (NCT01242488) and RA0083 (NCT01463059), which enrolled Western and
Asian RA patients respectively, who had failed previous anti-TNF therapy. OKZ
significantly reduced disease activity vs placebo (PBO).1 Here we report
results from the open-label extension (OLE) studies of these RCTs, RA0057 (NCT01296711) and
the RCTs, RA pts on MTX who had failed anti-TNF therapy were recruited from
Belgium, the US and the UK (RA0056), and Japan, Korea and Taiwan (RA0083). Pts
received PBO, subcutaneous (sc) OKZ 60/120/240 mg
every 2 weeks (Q2W) or 4 weeks (Q4W) (240 mg Q2W in RA0056 only), or (in RA0056
only) intravenous tocilizumab (TCZ) 8 mg/kg Q2W.
Completers were eligible for the OLEs, in which all pts received sc OKZ 120 mg Q2W + MTX (RA0057: 12.5–25.0 mg/wk to Wk 12, after which dose
could be reduced; RA0089: 6-16 mg/wk in Japan, 7.5-20
mg/wk in Korea and Taiwan). Pts with ongoing serious
adverse events (SAEs) were excluded.
primary objective of both studies was to assess long-term safety of OKZ;
secondary objectives were to assess long-term efficacy by change from OLE
baseline (BL) in Disease Activity Score 28 C-reactive protein (DAS28[CRP]) (4-variable). RA0057 was planned to run for 5
years, RA0089 to marketing application approval. Both OLEs were prematurely
terminated when the drug was partnered: data are available to Wk90 in RA0057
and Wk89 in RA0089. Pts receiving ≥6 months’ OL treatment are considered
completers. Data are reported for the full analysis set (all pts who received ≥1
dose of OKZ with ≥1 efficacy measurement in the OLE).
pts completed RA0056; 190 (114 OKZ, 40 PBO, 36 TCZ) enrolled in RA0057. 105 pts
completed RA0083; 103 (79 OKZ, 24 PBO) enrolled in RA0089. 67 (35.3%) pts
completed RA0057 (median [min–max] exposure: 51 [0–98] wks);
82 (79.6%) pts completed RA0089 (median [min–max] exposure: 40 [0–76] wks) (Table).
(TE) AEs occurred in 180 (94.7%) and 91 (88.3%) pts in RA0057 and RA0089
respectively; TEAEs and serious TEAEs are summarized in the Table.
measures continued to improve in the OLEs, most notably, as expected, in PBO
pts switching to OKZ. Disease activity in each treatment group was as follows:
Wk48 mean DAS28[CRP] change from BL in RA0057: PBO:
-1.76, OKZ:-0.60, TCZ: -0.43; in RA0089: PBO: -1.70, OKZ:-0.68. Data past Wk48
were not interpreted due to low pt numbers.
was well-tolerated, with an expected safety profile for this class of agent.
Reductions in disease activity were sustained to Wk48. These results support
the development of OKZ for the treatment of moderate-to-severe RA in Western
and Asian pts.
1. Genovese M. Ann Rheum Dis 2014;73(9):1607–14
To cite this abstract in AMA style:Genovese MC, Fleischmann R, Tanaka Y, Furst DE, Yamanaka H, Joshi R, Zhu W, Shao J, Mashimo H, Takeuchi T. Long-Term Safety and Efficacy of Olokizumab in Patients with Moderate-to-Severe Rheumatoid Arthritis Who Have Previously Failed Anti-TNF Treatment [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-olokizumab-in-patients-with-moderate-to-severe-rheumatoid-arthritis-who-have-previously-failed-anti-tnf-treatment/. Accessed August 17, 2017.
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